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Completed

NCT Number: NCT01827956

Role of FCγRIIIA and FCγRIIA Receptor Polymorphisms

Hypothesis:

Cetuximab, an anti-EGFR antibody, is used with radiotherapy in the treatment of locally advanced and inoperable upper aerodigestive tract cancers. Actually, no predictive biomarkers of Cetuximab antitumor activity are known in this setting. It has been shown recently that FCγRIIIA and FCγRIIA receptor polymorphisms played a role in antitumor activity of trastuzumab and cetuximab.

The investigators therefore hypothesized that FCγRIIIA and FCγRIIA receptor polymorphisms may play a predictive role in Cetuximab effectiveness in upper aerodigestive tract cancers with recurrence or metastatic disease that make them inaccessible to loco regional treatment.

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Key information

Conditions

Upper Gingival Squamous Cell Carcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institut Bergonié

Bordeaux, Aquitaine, 33000, France

About this study

Hypothesis:

Cetuximab, an anti-EGFR antibody, is used with radiotherapy in the treatment of locally advanced and inoperable upper aerodigestive tract cancers. Actually, no predictive biomarkers of Cetuximab antitumor activity are known in this setting. It has been shown recently that FCγRIIIA and FCγRIIA receptor polymorphisms played a role in antitumor activity of trastuzumab and cetuximab.

We therefore hypothesized that FCγRIIIA and FCγRIIA receptor polymorphisms may play a predictive role in Cetuximab effectiveness in upper aerodigestive tract cancers with recurrence or metastatic disease that make them inaccessible to loco regional treatment.

This study is a multicentre prospective pharmacogenetic observational study, conducted on locally advanced and inoperable upper aerodigestive tract cancers.

  • Blood sample for polymorphism identification (5 ml plastic tube with EDTA, taken at the start of treatment, at the same time as the blood samples routinely taken as part of standard care)
  • Collection of medical data at inclusion and at 4 months

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient with recurrent or metastatic squamous cell carcinomas of the upper aero-digestive tract
  • Patient with loco-regional extension not readily treatable
  • 18 years
  • Follow up in participant center
  • Patient information and consent for study participation
  • Patient presented in multidisciplinary meeting (RCP) in Aquitaine and for whom a treatment containing cetuximab has been proposed
  • Belong to a social security system

Exclusion criteria

  • Pregnancy
  • Patient with psychological, social, family or geographical reason, who could not be treated or monitored regularly by study criteria,
  • Patients deprived of liberty or under guardianship or who could not give consent for study participation
  • Inclusion in another study

Treatment and study plan

Cetuximab

Drug

Blood sample for identifying the polymorphism of FCGR3A and FCGR2A genes

Primary outcomes

  1. Polymorphism of FCGR2 Gene

    Time frame: At treatment initiation

    Polymorphism of FCGR2A gene is expressed according to 3 modalities : RR / RH / HH

    Genomic DNA will be extracted from whole blood tubes and redissolved in 100 µl 1× TE buffer and purified on GFX columns (Amersham-Biosciences). The quantity and quality of the DNA will be checked by agarose gel electrophoresis in the presence of ethidium bromide. Polymorphisms will be detected by PCR followed by pyrosequencing.

  2. Polymorphism of FCGR3A Gene

    Time frame: At treatment initiation

    Polymorphism of FCGR3A gene is expressed according to 3 modalities : FF / FV / VV.

    Genomic DNA will be extracted from whole blood tubes and redissolved in 100 µl 1× TE buffer and purified on GFX columns (Amersham-Biosciences). The quantity and quality of the DNA will be checked by agarose gel electrophoresis in the presence of ethidium bromide. Polymorphisms will be detected by PCR followed by pyrosequencing.

Secondary outcomes

  1. 4-month Non-progression Rate According to the Polymorphism

    Time frame: 4 months after treatment initiation

    The primary endpoint is the 4-month non-progression rate assessed according to RECIST criteria (or according to a clinical assessment if the patient does not undergo radiological examination). The response will be considered "no progression" in the following cases: complete response, partial response, or stable disease. In other cases (disease progression or unevaluable), the disease will be considered to be progressing.

    Response will be assessed at enrollment and at 4 months or until the first of the following events: disease progression or patient death.

  2. Overall Survival Rate

    Time frame: 12 months

    Overall survival: defined as the time between the first cycle of chemotherapy and the date of death, all causes. In the absence of death confirmation, survival data are censored from the date of last news

Sponsors and collaborators

Lead sponsor

Institut Bergonié

Other

Registry information

Official study title

Role of FCγRIIIA and FCγRIIA Receptor Polymorphisms in Cetuximab Activity Used in Palliative Treatment of Upper Aerodigestive Tract Tumours

Acronym: FCR-VADS

Important dates

Study start
2009
Primary completion
2011
Study completion
2013
First posted
Apr 10, 2013
Registry last updated
Dec 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.